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目的系统评价传统小梁切除术中使用丝裂霉素C(MMC)与5-氟尿嘧啶(5-Fu)的疗效及安全性。方法计算机检索MEDLINE(1966～2008年10月)、EMbase(1966～2008年10月)、Cochrane协作网眼和视力组(2008年3期)数据库及中国生物医学文献数据库(1979～2008年10月),并采用手工检索等方法收集会议文献,收集所有相关随机对照试验。在评价纳入研究的方法学质量后采用RevMan5.0软件进行Meta分析。结果共纳入9个随机对照试验,包括482例患者(495只患眼)。Meta分析结果表明,在手术失败高风险组中,与MMC相比,5-Fu可增加术后并发症发生率[RR=-5.74,95%CI(-9.91,-1.58)];应用MMC与5-Fu对传统小梁切除术后眼压降低率[WMD=-2.31,95%CI(-7.34,2.71)]、手术成功率[RR=1.13,95%CI(0.91,1.39)]、术后视力下降(≥3行)[RR=1.46,95%CI(0.43,4.94)]差异均无统计学意义;在手术失败低风险组中,应用MMC与5-Fu在传统小梁切除术后手术成功率及术后并发症发生率方面差异均无统计学意义[RR=1.10,95%CI(0.99,1.22);RR=1.00,95%CI(-6.21,8.21)]。结论传统性小梁切除术手术失败高风险组和低风险组中,使用MMC和5-Fu对手术成功率、术后视力变化等方面差异均无统计学意义;但在高风险组中5-Fu可增加术后并发症发生率,MMC与5-Fu对传统小梁切除术后眼压降低率的作用何者更优尚不确定。但在传统小梁切除术中,两种药物用药方式对药代动力学的影响机制,以及经济学评价尚待进一步研究。因本系统评价纳入研究病例数较少,上述结论有待更多设计严谨的大样本随机对照试验加以验证,以增强论证强度。
Objective To evaluate the efficacy and safety of mitomycin C (MMC) and 5-fluorouracil (5-Fu) in traditional trabeculectomy. Methods The data from MEDLINE (1966 ~ October 2008), EMbase (from 1966 to October 2008), Cochrane Collaboration Eye and Eye Group (3/2008) and Chinese Biomedical Literature Database (1979 ~ 2008) , And manual documentation was used to collect conference literature and collect all relevant randomized controlled trials. Meta-analysis was performed using RevMan 5.0 software after evaluating the quality of the included studies. Results A total of 9 randomized controlled trials were included, including 482 patients (495 eyes). Meta-analysis showed that 5-Fu increased the incidence of postoperative complications compared with MMC in high-risk patients with failed surgery [RR = -5.74,95% CI (-9.91, -1.58)]; 5-Fu reduced the intraocular pressure after trabeculectomy [WMD = -2.31,95% CI (-7.34,2.71)], the success rate of surgery [RR = 1.13,95% CI (0.91,1.39)], There was no significant difference in the decrease of visual acuity (≥3 rows) [RR = 1.46,95% CI (0.43, 4.94)]. In the low risk group, the application of MMC and 5-Fu in the trabeculectomy There were no significant differences in the success rate of surgery and the incidence of postoperative complications [RR = 1.10,95% CI (0.99,1.22); RR = 1.00,95% CI (-6.21,8.21)]. Conclusions There is no significant difference in the success rate of operation and changes of visual acuity after using MMC and 5-Fu among the high-risk group and low-risk group who failed the traditional trabeculectomy. However, in the high-risk group, 5- Fu can increase the incidence of postoperative complications, MMC and 5-Fu trabeculectomy after the reduction rate of intraocular pressure which is better for more uncertain. However, in traditional trabeculectomy, the pharmacokinetics of the two drug modes of administration, as well as economic evaluation remains to be further studied. Due to the small number of cases included in this systematic review, the above conclusion needs to be verified by more carefully designed large sample randomized controlled trials to enhance the strength of argumentation.